An interventional study of Immersive Virtual Reality in Dental Anxiety in Children, Dental Pain and Virtual Reality, sponsored by University of Gaziantep. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Supportive care
This study evaluated whether immersive virtual reality (VR) can help reduce pain and dental fear and improve behavioral cooperation in children undergoing restorative dental treatment. Children aged 8-12 years who required treatment of primary molars were randomly assigned to either a VR group or a control group. Children in the VR group watched an age-appropriate animated video through a VR headset during local anesthesia and dental treatment, while children in the control group received routine dental treatment without VR. Pain, dental anxiety, dental fear, behavioral cooperation, emotional responses, physiological measurements, treatment duration, and parent and clinician satisfaction were assessed and compared between the two groups.
This single-center, two-arm, parallel-group randomized controlled clinical trial evaluated the effects of immersive virtual reality (VR) distraction during restorative dental treatment in children aged 8-12 years.
Children requiring restorative treatment of mandibular second primary molars with occlusal carious lesions classified as ICDAS II codes 2-4 were eligible for participation. Eligible children were randomly assigned in a 1:1 ratio to either an immersive VR group or a control group. Randomization was performed using a computer-generated sequence, with allocation concealed in sequentially numbered, opaque, sealed envelopes.
Children in the VR group used an immersive VR headset during the dental procedure and watched the same age-appropriate animated video throughout treatment. The headset was placed approximately one minute before administration of local anesthesia and remained in place until completion of the restorative procedure. Children in the control group received routine restorative dental treatment without a distraction intervention.
All dental procedures were performed by the same calibrated pediatric dentist according to a standardized clinical protocol. Local anesthesia was administered using an inferior alveolar nerve block with 1.8 mL of 2% lidocaine through a 30-gauge dental needle. The restorative procedure was performed on mandibular second primary molars and lasted approximately 10-15 minutes.
The primary outcome was children's pain perception, assessed using the Wong-Baker Faces Pain Rating Scale. Secondary outcomes included behavioral cooperation, dental anxiety, dental fear, emotional responses, physiological parameters, parent and clinician satisfaction, and treatment duration.
Pain was assessed during and immediately after treatment. Behavioral cooperation and physiological parameters were assessed before, during, and after treatment. Dental anxiety and emotional responses were assessed before and after treatment, while dental fear was evaluated using a validated questionnaire. Parent and clinician satisfaction were assessed immediately after treatment.
The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. The study protocol received approval from the Sanko University Clinical Research Ethics Committee (KAEK-028-1). Written informed consent was obtained from the parents or legal guardians, and verbal assent was obtained from the participating children.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's enrollment of 70 is below the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →University of Gaziantep is the lead sponsor of 105 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children aged 8-12 years. Children requiring dental treatment under local anesthesia. Children who are able to understand and follow the study instructions. Children whose parents/legal guardians provide written . Children who provide age-appropriate assent to participate.
Exclusion Criteria:
Children with systemic, neurological, psychiatric, cognitive, or developmental conditions that may affect anxiety or pain assessment.
Children with visual or auditory impairments that prevent appropriate use of the VR system or communication with the investigator.
Children with a history of seizures or other conditions for which VR use is .
Children who refuse to participate or whose parents/legal guardians withdraw consent.
Children who are unable to complete the dental treatment or study assessments.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received immersive virtual reality-based audiovisual distraction during standardized restorative dental treatment. The VR headset was fitted approximately 1 minute before local anesthesia and remained in place throughout the restorative procedure. Participants watched a standardized age-appropriate animated video (Pırıl) for approximately 10-15 minutes.
Behavioral: Immersive Virtual Reality
Participants received routine restorative dental treatment without a distraction intervention. Local anesthesia and restorative procedures were performed according to the same standardized clinical protocol used for the virtual reality group.
Immersive virtual reality-based audiovisual distraction using a standardized, age-appropriate animated video during restorative dental treatment.
Pain Perception
Pain perception was assessed using the Wong-Baker Faces Pain Rating Scale (WBFPRS), with higher scores indicating greater pain intensity.
Time frame: During treatment (T1) and immediately after completion of the restorative procedure (T2)
Plan to share: No
Ran from May 2025 to primary completion in Aug 2025, 3 months.
Of 44 non-industry interventional studies with no phase under Toothache, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's 3 months is below that.
Counting every sponsor, half of 45 studies reached it within 5 months; a quarter within 3 and three quarters within 12.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.